| Autor: |
Connor, Kathryn M., Mahoney, Erin, Jackson, Saheeda, Hutzelmann, Jill, Xin Zhao, Herring, W. Joseph, Nan Jia, Snyder, Ellen, Snavely, Duane, Michelson, David, Roth, Thomas |
| Předmět: |
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| Zdroj: |
International Journal of Neuropsychopharmacology; Aug2016, Vol. 19 Issue 8, p1-10, 10p, 1 Diagram, 6 Charts, 1 Graph |
| Abstrakt: |
Background: Filorexant (MK-6096) is an orexin receptor antagonist; here, we evaluate the efficacy of filorexant in the treatment of insomnia in adults. Methods: A double-blind, placebo-controlled, randomized, two 4-week–period, adaptive crossover polysomnography study was conducted at 51 sites worldwide. Patients (18 to <65 years) with insomnia received 1 of 4 doses of oral filorexant (2.5, 5, 10, 20 mg) once daily at bedtime during one period and matching placebo in the other period in 1 of 8 possible treatment sequences. Polysomnography was performed on night 1 and end of week 4 of each period. The primary endpoint was sleep efficiency at night 1 and end of week 4. Secondary endpoints included wakefulness after persistent sleep onset and latency to onset of persistent sleep. Results: A total of 324 patients received study treatment, 315 received ≥1 dose of placebo, and 318 ≥1 dose of filorexant (2.5 mg, n = 79; 5 mg, n = 78; 10 mg, n = 80; 20 mg, n = 81). All filorexant doses (2.5/5/10/20 mg) were significantly superior to placebo in improving sleep among patients with insomnia as measured by sleep efficiency and wakefulness after persistent sleep onset on night 1 and end of week 4. The 2 higher filorexant doses (10/20 mg) were also significantly more effective than placebo in improving sleep onset as measured by latency to onset of persistent sleep at night 1 and end of week 4. Filorexant was generally well tolerated. Conclusions: Orexin receptor antagonism by filorexant significantly improved sleep efficiency in nonelderly patients with insomnia. Dose-related improvements in sleep onset and maintenance outcomes were also observed with filorexant. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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